The present invention relates to medical devices used in implant surgery. More specifically, the present disclosure relates to an inflatable penile prosthesis assembly, or penile implant.
Even as late as the early 1970's, the conventional view of impotence was that ninety percent of cases were psychologically based, whereas only ten percent of the cases were caused by a physical condition. Today, doctors and scientists understand that the overwhelming majority of cases are caused by a physical condition. According to a recent study, fifty-two percent of men between the ages of forty and seventy self-reported that they suffer from some type of erectile dysfunction. Another study estimated that over thirty million American men and their partners suffer from erectile dysfunction.
Advertisements for pharmaceutical treatments for impotence have become ubiquitous. More and more men and their partners now are seeking treatment for impotence. In the recent past, it was estimated that only one in twenty sufferers of erectile dysfunction sought treatment from their doctors. Pharmaceutical treatments are successful for only a subset of impotence sufferers. Other treatments, including more invasive treatments are necessary for many men. These treatments include injection therapy, vacuum devices and penile prosthesis.
Penile implants are disclosed in U.S. Pat. Nos. 3,853,122; 4,009,711; 3,954,102; 4,537,183; 4,566,466; 3,987,789, 4,350,151; 5,788,627; 4,651,721; 5,141,509; 5,851,176; 5,167,611; 6,443,887 and 6,533,719. Commercial examples of penile prosthesis include the AMS 700 CX™ and the AMS 700 Ultrex™ available from American Medical Systems of Minnetonka, Minn. and the Mark II Inflatable Penile Prosthesis previously available from Mentor of Santa Barbara, Calif. The Mark II prosthesis included an injection port in a resipump element.
The penile implant has been used for decades and provides a selected and reliable erection. Inflatable penile implants typically include a pair of cylinders. In some instances, these cylinders are connected to a fluid-filled reservoir with a pump and valve assembly. The two cylinders are normally implanted into the corpus cavernosae of the patient's penis and the reservoir is typically implanted into the patient's abdomen. The pump assembly is implanted in the scrotum. During use, the patient actuates the pump and fluid is transferred from the reservoir through the pump and into the cylinders. This results in the inflation of the cylinders and produces rigidity for a normal erection. Then, when the patient desires to deflate the cylinders, a valve assembly within the pump is actuated in a manner such that the fluid in the cylinders is released back into the reservoir. This deflation returns the penis to a flaccid state.
A type of inflatable penile implant includes one or more cylinder(s) having inflation chamber(s) that are disposed within the penis (corpus cavernosae). The penile implant includes a remote pump assembly that is connected via tubing to the cylinder(s). The tubing is connected to the cylinder(s) at tubing junction(s). In prior art examples, such as those in United States Patent Nos. among others, show a straight bore extending through the strain relief and into the inflation chamber. Fluid is transferred from the pump assembly, through the tubing, and into the cylinder(s).
Prior art methods for implanting inflatable prostheses typically included the step of leaving the cylinders inflated or partially inflated in the immediate post operative period. This allows the tissue surrounding the cylinder to heal while the cylinder is in an inflated condition. However, in systems that include a balloon like reservoir, this meant that the balloon-like reservoir was in a deflated or partially empty condition. In the prior art procedures, the body healed with the reservoir in such a condition. Unfortunately, scar tissue can form that can result in discomfort or pain when the reservoir was thereafter filled. It is also believed that the scar tissue can cause the cylinder(s) of the system to partially inflate at unintended times or prevent the cylinder(s) of the system from completely deflating.
U.S. Pat. No. 5,250,020 discloses a unitary inflatable penile prosthesis. This prosthesis includes an injection port with flexible silicone rubber. The injection port is said to be capable of partially prefilling the prosthesis at the time of manufacture, thereby relieving the surgeon of the task of assembling the components at the time of implantation.
U.S. Pat. No. 4,766,889 discloses an infusion erectile system. The system includes a septum and reservoir.
Some patients or surgeons complain of penile shaft shortening and/or insufficient cylinder flaccidity following penile implantation surgery. Although rare, some penile implants become infected and leaks in the hydraulic system develop in some.